Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -393

Accepted - Volume 6

Comment Record
Commentor Ms. Jeannette Baker Date/Time 2002-09-11 02:49:39
Organization Ms. Jeannette Baker
Category Individual

Comments for FDA General
Questions
1. Are there arguments for regulating speech about drugs more comprehensively than, for example, about dietary supplements? What must an administrative record contain to sustain such a position? In particular, could FDA sustain a position that certain promotional speech about drugs is inherently misleading, unless it complies with FDA requirements? Does anything turn on whether the speech is made to learned intermediaries or to consumers? What is the evidentiary basis of such a distinction? The direct advertising of mediations via the media to members of the publc serves only the makers of the product. In matters of health, the knowledge of the physician and needs of the patient should be the way in which medications are prescribed. Patients being bombarded with ads for medications for which theadvertisers don't even bother to say what the medications are used for is ABSURD!That offers the proof that this systemof health care is contaminated by theadvertsiing of the highest priced new medications for which no need is identified!Also, my daughter in law informs me thtat her clinic, every Tuesday is free lunch day.. a banquet provided by drugreps. Now I wonder... does business doanything that does not pay?? Are theypromoting the lower cost, tried and truemeds? hahaha, NOT ON YOUR LIFE! Theypush flashy, 'on the edge' blow your soxoff price. I take Prilosec. $385 a month. Not enoughprofit for them, so enter the 'Purple Pill at a significantly higher price.Same drug, just 40 mg. where Prilosec is20 mg. Whole new promotion for Nexium..but same drug..just stronger. But we allknow it was because Prilosec was loosingpatant.. LOUSY MEDICAL SYSTEM, The big question: Can the public haveeven a vague chance of having their drsprescribe the best medications with thisadvertising standing in the exam room asan invisible third party? I think not!
2. Is FDA's current position regarding direct-to-consumer and other advertisements consistent with empirical research on the effects of those advertisements, as well as with relevant legal authority? What are the positive and negative effects, if any, of industry's promotion of prescription drugs, biologics, and/or devices? Does the current regulatory approach and its implementation by industry lead to over-prescription of drugs? Do they increase physician visits or patient compliance with medication regimes? Do they cause patient visits that lead to treatment for under-diagnosed diseases? Does FDA's current approach and its implementation by industry lead to adequate treatment for under-diagnosed diseases? Do they lead to adequate patient understanding of the potential risks associated with use of drugs? Does FDA's current approach and its implementation by industry create any impediments to the ability of doctors to give optimal medical advice or prescribe optimal treatment? We individuals are considered responsible for the way we eat, and the medicine andsupplemens we injest.The claims make MUST be as reliable for them as the appliances, cars, or other products we buy which have specific claims of performance, durability, funcitonality, and safety attatched.No claim should be made which cannot bescientifically substantiated, and provento be beneficial for our health.
3. May FDA distinguish claims concerning conventional foods from those relating to dietary supplements, taking into account limits on claims that can be made about foods in the Nutrition Labeling and Education Act, 21 U.S.C. 301, 321, 337, 343, 371? What must an administrative record contain to sustain or deny claims on food labels? How can information best be presented in a succinct but non-misleading fashion? To what extent do assertions in claims need qualifications or disclaimers added to the label to avoid any misconceptions that consumers may draw? Is there a basis to believe that consumers approach claims about conventional foods and dietary supplements differently? I must rely upon my food, medicine and supplements to contain complete, accurateand truthful information!
4. Should disclaimers be required to be in the same (or smaller or larger) size of type and given equal prominence with claims? Is there any relevant authority or social science research on this issue? if claims must be substantiated, disclaimers would not be needed!However, should they be able to claim things not proven, they YES make the disclimer larger! We are not food engineers, so members of the publc arehopeful of claims. If the info is NOtCORRECT, OR OTHER INFO APPLIES, YES THE DISCLAIMER MUST BE LARGER.
5. How can warnings be made most effective in preventing harm while minimizing the chances of consumer confusion or inattention? Is there any evidence as to which types of warnings consumers follow or disregard? A seperate panel on label for 'warning' is the only logical thing to do.
6. What arguments or social science evidence, if any, can be used to support distinguishing between claims made in advertisements and those made on labels? Does the First Amendment and the relevant social science evidence afford the Government greater latitude over labels? If we can't yell fire in a theater to uphold our first ammendment rights, then doing harm to the health and life of people by misrepresenting food, medicine and supplements must certainly hold thesame weight in 'do no harm'
8. Do FDA's speech-related regulations advance the public health concerns they are designed to address? Are there other alternative approaches that FDA could pursue to accomplish those objectives with fewer restrictions on speech? If we would allow the advertisers to use the flim flam of carnival barkers to pursude us to seek, buy and use products which are not proven safe and effecitivefor uses promoted.. we have gone brain dead!
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? REQURE HONESTY, TRUTH, AND PROOF OF CLAIMS. OR SHUT THEM UP. WE HAVE A RIGHT TO NOT BE MARKETED TO BY MAKERS OF HIGHTER AN HIGHER PRICED PRODUCTS WHICH CAN UNDERMINE OUR HEALTH AND HEALTH CARE FINANCING, WHILE PROMOTING PRODUCTS WHICH MAY NOT WORK, OR DAMAGE OUR HEALTH




EC -393